Kornimate/medical-research-clean huggingface dataset:
enteroendocrine cells before and after sleeve gastrectomy

Conditions: Obesity

Summary: morbidly obese patients exhibit impaired secretion of satiation hormones which may contribute to the development of obesity. bariatric surgery is associated with weight loss and dramatic increase in the secretion of satiation hormones, but the underlying mechanism remains unknown. the investigator's goal is therefore to examine patients before and after sleeve gastrectomy and compare findings to lean controls.

morbidly obese patients exhibit impaired secretion of satiation hormones cholecystokinin (cck), glucagon-like peptide 1 (glp-1) and peptide yy (pyy), which may contribute to the development of obesity. bariatric surgery is associated with weight loss and dramatic increase in the secretion of satiation hormones, but the underlying mechanism remains unknown. a better understanding of mechanisms involved will assist in development of non-invasive therapeutic strategies. the investigator's goal is therefore to examine patients before and after sleeve gastrectomy and compare findings to lean controls. gastric and intestinal mucosa will be collected by endoscopy from morbidly obese subjects before and 3 months after sleeve gastrectomy. in addition, lean controls will be examined. expression of various gut peptides will be assessed by immunohistochemistry and quantitative polymerase chain reaction (pcr).

Eligibility criteria:
inclusion criteria: morbidly obese patients scheduled for sleeve gastrectomy * bmi \> 35 kg/m2 * age: \> 18-65 years lean, healthy controls * bmi \> 18 and \< 28kg/m2 * age: \>18-40 years exclusion criteria: * bleeding diathesis * previous surgery on the gastrointestinal tract (appendectomy acceptable)
skin sensitization test (modified draize-95 test)

Conditions: Skin Sensitisation

Summary: skin sensitization test (modified draize-95 test) to support a low dermatitis potential claim for a blue non sterile powder free nitrile examination gloves. this study is a ript (repeat insult patch test) to evaluate whether residual chemical additives at the level that may induce type iv allergy in the nonsensitized general user population are present in a finished blue non sterile powder free nitrile examination glove.


Eligibility criteria:
inclusion criteria: * subjects must be aged 18 to 65 years, inclusive; * subjects who have not participated in other voluntary testing for at least 30 days; * subjects must execute an informed consent form that includes a hipaa statement; and * subjects must be capable of understanding and following directions. * female subjects must produce a negative urine pregnancy test prior to the initiation and also at the completion of the trial. exclusion criteria: * subjects who are in ill health, as determined by the pi; * subjects who are taking medication, other than birth control, which could influence the purpose, integrity or outcome of the trial; * subjects who have used topical or systemic corticosteroids, anti-inflammatories, antihistamines or antibiotics within 2 weeks prior to trial initiation or during their participation on this trial; * female subjects who are pregnant as evidenced by a urine pregnancy test, planning to become pregnant or lactating during the trial; * subjects who have a history of adverse reactions to cosmetics, otc drugs, or other personal care products; * subjects who introduce the use of any new cosmetic, toiletry or personal care products during the trial; * subjects with any visible skin disease that might be confused with skin reactions caused by the test material; * subjects with any knowledge or indication of existing type iv allergy (delayed hypersensitivity) to natural rubber chemical additives; * subjects with any indication of existing type i allergy (immediate hypersensitivity) to natural rubber proteins; * subjects with a history of frequent irritation; or * subjects who have received endogenous or exogenous immunosuppressive treatment (or prolonged exposure to sun).

Keywords: modified draize-95 test skin sensitisation repeat insult patch test
impact of interactive icu diary on psychological distress

Conditions: Critical Illness

Summary: this study investigates the effectiveness of a technology-driven, interactive icu diary in reducing psychological distress, specifically anxiety, depression, and stress, in icu patients. a single-blind, parallel-group randomized controlled trial will include 56 conscious icu patients. the primary outcome measures are the depression, anxiety, and stress scale-21 (dass-21) and the euroqol instrument (eq-5d), assessed at icu admission, discharge, and one month post-discharge.

this study investigates the effectiveness of a technology-driven, interactive icu diary in reducing psychological distress, specifically anxiety, depression, and stress, in icu patients. a single-blind, parallel-group randomized controlled trial will include 56 conscious icu patients, randomly assigned to either the interactive diary group or the standard care group. the interactive diary allows patients to share their feelings and needs via a platform, while family members can send supportive messages, pictures, and videos. healthcare providers can connect with families and monitor patient conditions through the platform. the primary outcome measures are the depression, anxiety, and stress scale-21 (dass-21) and the euroqol instrument (eq-5d), assessed at icu admission, discharge, and one month post-discharge. the expected results indicate that the interactive diary will significantly alleviate psychological distress during the icu stay and improve post-discharge quality of life, providing valuable insights into enhancing the mental health and overall well-being of icu patients.

Eligibility criteria:
inclusion criteria: * age 18 years or older * clear consciousness and able to communicate in mandarin, taiwanese, or hakka * expected icu stay of at least 72 hours * ability to operate a smart device and use social media applications exclusion criteria: * presence of delirium before joining the study (intensive care delirium screening checklist score ≥ 4) * physical, auditory, or visual impairments preventing the use of smart devices history of epilepsy, cognitive impairments (e.g., hepatic encephalopathy, dementia), or psychiatric disorders * richmond agitation-sedation scale score not between +1 and -1 (indicating excessive sedation or agitation) * acute physiology and chronic health evaluation score (apache-ii) \> 25 within the first 24 hours of icu admission (indicating \> 50% mortality rate)
preoperative carbohydrate loading in elective surgery

Conditions: Surgery

Summary: postoperative infectious morbidity remain the most frequent, threatening and costly event after major surgery. maintenance of postoperative euglycemia might be a key factor to prevent such complications and given the preliminary data on the positive effect of carbohydrate load on glucose metabolism it might also be valuable in improving outcome. if this treatment will be proved effective on relevant outcome measure such as rate of infections, it might be used routinely and extensively because preoperative carbohydrates administration is cheap, simple and applicable by everyone in any surgical ward. the aim of the trial is to evaluate if the normalization of blood glucose by means of preoperative oral administration of maltodextrine, in patients candidate to elective major surgery, may be effective in improve surgical morbidity.


Eligibility criteria:
inclusion criteria: * patients candidate for elective major (expected duration \> 2 hrs) abdominal, urologic, and gynecologic surgery exclusion criteria: * diagnosis of diabetes mellitus, * baseline plasma glucose level \> 125 mg/dl, * pancreatic resection, * asa score \> 3, * malnutrition (loss of weight greater than 10%), * emergency surgery, * documented gastro-esophageal reflux, * corticosteroid therapy, * ongoing infection, * pregnancy, * age \< 18 years, * denied written informed consent

Keywords: carbohydrate glucose metabolism surgery, outcome major elective surgery urology hyperglicemia
irrisept versus standard of care in the prevention of surgical site infections

Conditions: Surgical Site Infection

Summary: the purpose of this study was to compare the rate of surgical site infections in patients randomized to irrisept versus soc, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.

the trial was explained to potential subjects, the informed consent was completed and and eligibility was verified. after this, the subjects were randomized to irrisept or soc and an open abdominal laparotomy with primary closure due to (1) blunt or penetrating abdominal trauma or (2) acute surgical abdomen was performed. the follow-up visit was performed approximately 30 days later.

Eligibility criteria:
inclusion criteria: 1. is male or female, 18 years of age or older 2. has provided written informed consent or has surrogate consent provided by a legally authorized representative (lar) 3. has experienced abdominal trauma, blunt or penetrating, requiring open abdominal laparotomy with primary closure or 4. has experienced acute surgical abdomen requiring open abdominal laparotomy with primary closure exclusion criteria: 1. known allergy to chlorhexidine gluconate (chg) 2. estimated abbreviated injury scale (ais) score of six (6) at the time of surgery, for all trauma patients 3. american society of anesthesiologists physical status classification (asa) score of five (5) or greater (as asa scoring is a subjective measure, if the pi finds the patient stable enough for study participation despite a score of 5, enrollment may continue.) 4. female volunteers who are pregnant and/or breast feeding 5. damage control laparotomy 6. abdominal incision created prior to operating room (i.e. incision made in trauma bay to cross clamp the aorta) 7. currently enrolled in an ongoing, interventional, randomized clinical trial
transcranial direct current stimulation augmented exposure and response prevention for obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: this study is investigating whether combining noninvasive brain stimulation with behavior therapy can help to improve outcomes for obsessive-compulsive disorder (ocd). exposure and response prevention (erp) -- a specific type of behavior therapy -- is a first line treatment for ocd. this study will test whether a form of noninvasive brain stimulation called transcranial direct current stimulation (tdcs), can help erp work better.


Eligibility criteria:
inclusion criteria: * current primary ocd diagnosis and current yale-brown obsessive-compulsive scale (y-bocs) total score of ≥16 * 18-65 years of age * ability to speak, read, write, and understand english sufficiently well to complete study procedures and provide informed consent * right-handed * no use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry. psychiatric medications will be limited to the following: serotonin reuptake inhibitors (sri; including clomipramine), combination antidepressants (including bupropion and serotonin-norepinephrine reuptake inhibitors), buspirone, benzodiazepines, and/or stimulants * naive to tdcs exclusion criteria: * active substance use disorder * lifetime diagnosis of psychotic or bipolar mood disorder * previous minimally adequate trial of erp (e.g., at least 16 sessions including both therapist and self-directed exposure and response prevention) * therapy outside the study protocol which has evidence for efficacy with ocd during the study intervention period * active suicidal or homicidal ideation * organic brain disease or injury * any health problems that would interfere with study participation, including contraindications to tdcs (e.g., skin condition, mental implant in skull) * women who are pregnant or breastfeeding. all women participants of child-bearing age are required to have a negative pregnancy test prior to treatment, and must use medically acceptable birth control during study participation. medically acceptable birth control includes: established oral, injected, implanted, or vaginal ring hormonal contraception, an intrauterine device (iud), two barrier contraception methods (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), or having a vasectomized partner * use of anticonvulsant medications (including depakote, gabapentin, tegretol, dilantin, lamictal) and/or glutamate-acting agents (including n-acetylcysteine, riluzole, amantadine, memantine).
dutasteride for the reduction of alcohol use in male drinkers

Conditions: Alcoholism; Alcohol Abuse; Alcohol Dependence

Summary: the purpose of this study is to evaluate whether dutasteride is safe and effective for reducing alcohol use in male drinkers who want to stop or reduce their drinking. the investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and that, compared to placebo treatment, dutasteride will result in a greater reduction in the amount of alcohol consumed per week. the study sample size is of a pilot scale and is designed to provide additional support for the study hypothesis and provide an estimate of likely effect sizes in order to design a more definitive study.


Eligibility criteria:
inclusion criteria: * male outpatients age 18 to 65 years * have an average weekly ethanol consumption of \>24 standard drinks * be able to read english at the 8th grade or higher level and show no evidence of significant cognitive impairment * be willing to nominate an individual who will know the patient's whereabouts in order to facilitate follow up during the study * be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels) exclusion criteria: * have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation * have a serious psychiatric illness (e.g., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mood or mental disorders, current eating disorder symptoms, or substantial suicide or violence risk) on the basis of history or psychiatric examination * have a current diagnosis of drug dependence (other than nicotine or alcohol dependence) * have a current diagnosis of alcohol dependence who on clinical examination by a physician, are deemed to be too severely alcohol dependent to permit them to participate in a placebo-controlled pilot study * have a history of hypersensitivity to dutasteride * current or past 4 month use of finasteride (propecia), dutasteride (avodart) or testosterone * are currently taking psychotropics other than a single antidepressant with stable dose for at least 4 weeks or a non-benzodiazepine sleep medication * are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug

Keywords: randomized trial medication for heavy drinking dutasteride treatment
lupus atherosclerosis prevention study

Conditions: Systemic Lupus Erythematosus

Summary: cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in systemic lupus erythematosus (sle) in developed countries. coronary artery disease and stroke contribute to long-term morbidity in surviving patients. atherosclerosis in sle is multifactorial, with immune/inflammatory endothelial damage, traditional cardiovascular risk factors, and prothrombotic factors all playing important roles. multiple groups have shown that hyperlipidemia is predictive of later atherosclerosis in sle. in the general population, statins have become the drug of choice in preventing atherosclerotic events, through two mechanisms: lipid lowering that helps to prevent progression, and stabilization of plaques to prevent rupture. in the lupus atherosclerosis prevention trial we will determine if atorvastatin reduces the progression of atherosclerosis on helical computed tomography (ct) and carotid duplex. recent work has confirmed that statins have an immunomodulatory role. this study will also determine whether statins improve clinical lupus activity or lupus serologies (anti-dsdna and complement).


Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of sle, confirmed by a faculty rheumatologist at johns hopkins. * patients must be 18 years of age or older * give informed consent. exclusion criteria: * sle patients with a known atherosclerotic event, such as angina, myocardial infarction, or stroke, with an abnormal lipid profile for which a statin would be standard of care, are excluded. * pregnant patients (or patients planning to become pregnant in the next two years) are excluded. * patients who have known chronic liver disease, have unexplained elevation of their liver enzymes greater than 2 times the upper limit of normal , or an elevated cpk greater than 1.5 times the upper limit of the normal value for the patient's racial group, are excluded. * patients with triglycerides greater than 500 mg/dl or ldl greater than 190 in the absence of 2 risk factors (and who are unwilling to participate in a formal nutritional/lifestyle modification program that we recommend for them) are excluded.

Keywords: atherosclerosis, sle, statins
safety study of prtx-100 with methotrexate or leflunomide to treat active rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to determine the safety and tolerability of prtx-100 when various doses are given 5 times at weekly intervals to patients with active rheumatoid arthritis that are taking methotrexate or leflunomide. the drug is administered in a physician's office via an intravenous infusion. prtx-100 may be effective in rheumatoid arthritis by suppressing the immune responses. prtx-100 is a highly-purified bacterial protein called staphylococcal protein a. in this study, cohorts of patients with active ra will receive sequentially higher doses of prtx-100. there will be an inactive placebo cohort for comparison. patients who do not attain low ra disease activity, by a commonly used measure, will leave the study at 3 months after their first dose of study drug.


Eligibility criteria:
inclusion criteria: * active ra with disease duration of not less than 6 months * concomitant stable methotrexate or leflunomide therapy exclusion criteria: * diagnosis of any other inflammatory arthritis * acr functional classification of iv * significant systemic involvement secondary to ra (except for secondary sjogren's syndrome) * history of clincally significant hypogammaglobulinemia, common variable immunodeficiency, or humeral immunodeficientncy * history of active tuberculosis, pro-thrombotic disorder, venous thrombosis requiring anti-coagulation, substance abuse, or serious psychiatric condition * history of allergy or hypersensitivity to aspirin or non-steroidal cyclooxygenase inhibitors, staphylococcal protein a * history or presence of malignancy (except for surgically treated basal or squamous cell carcinoma of the skin at least 3 months prior to the start of study medication) * uncontrolled diabetes or type 1 diabetes * unstable ischemic heart disease * serious active or recurrent infection, hepatic cirrhosis, or other medically unstable condition * systemic autoimmune diseases other than ra (such as systemic lupus erythematosus, scleroderma, inflammatory bowel disease, inflammatory myopathy) * positive for hiv, hepatitis b surface antigen, or hepatitis c antibody * pregnant or nursing females * inadequate hepatic, renal, or hematologic function * receipt of live vaccine within 5 weeks of start of study medication * concomitant administration of other biologic or non-biologic dmards, corticosteroids, or anti-cd20 antibodies

Keywords: arthritis rheumatoid methotrexate leflunomide
fluoride varnish for treatment of white spot lesions

Conditions: White Spot Lesions

Summary: study will look at ability of fluoride varnish to remineralize white spot enamel lesions that can occur around the edge of fixed orthodontic brackets.

to determine the efficacy of 5% sodium fluoride varnish with tricalcium phosphate in reverting white spot lesions after fixed orthodontic treatment, compared with a fluoride gel.

Eligibility criteria:
inclusion criteria: * no systemic disease * has completed fixed orthodontic treatment, brackets debonded * has at least two teeth with whitre spot lesions * has received conventional periodontal therapy after orthodontic tretament exclusion criteria: * presence of enamel hypoplasia or dental fluorosis * presence of tetracycline pigmentation * periodontal pocketing of 3mm or greater * taking antibiotics * presence of carious cavities * allergy to fluoride gel / varnish being used in study

Keywords: white spot lesions fixed orthodontic brackets fluoride varnish fluoride gel
effect of varying the protein and dietary fiber content of energy bars on their glycemic and insulinemic impact

Conditions: Diabetes Mellitus

Summary: the purpose of this study was to determine the effect of changing the amounts of resistant starch, whey protein and sugar on the blood glucose and insulin responses elicited by energy bars. the investigators also compared the glucose and insulin responses to the rates at which the food bars were digested in-vitro (in the test tube). the investigators thought increasing resistant starch and reducing sugar would reduce the glucose and insulin responses, and that adding protein would reduce glucose and increase insulin. the investigators also thought the glucose and insulin responses in people would be related to the rate of digestion of the food bars in-vitro.


Eligibility criteria:
inclusion criteria: * body mass index 20.0 to 34.9 kg/m² * fasting serum glucose \<7.0mmol/l * non-smoker exclusion criteria: * known to have diabetes * use of medications or presence of a medical condition considered by the principal investigator to increase risk to the participant or affect the results * known food allergy of any kind

Keywords: blood glucose blood insulin humans postprandial carbohydrate protein resistant starch sugar
a study of dasatinib in patients with chronic myelogenous leukemia who are resistant or intolerant of imatinib mesylate

Conditions: Leukemia, Myeloid, Chronic; Leukemia, Lymphocytic, Acute, L2

Summary: the purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (cml) or philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) who no longer can tolerate treatment with imatinib. the safety of the treatment will also be studied.


Eligibility criteria:
inclusion criteria: * diagnosis of accelerated phase or blast phase cml or ph+ all * intolerant or resistant to imatinib mesylate * 18 years of age or older * ecog performance 0-2 (greater than 50% of time out of bed) * adequate liver and kidney function exclusion criteria: * pregnant or breastfeeding females * history of significant cardiac disease * history of significant bleeding disorder (not cml) * prisoners

Keywords: chronic myeloid leukemia accelerated and blast phase leukemia, acute, philadelphia-positive